(270 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of polycarbonate pipettes, with no mention of AI or ML.
No
The device is described as pipettes used for the manipulation of cells (e.g., blastomeres, oocytes, embryos) in vitro, primarily in a lab setting, rather than for directly treating a patient's disease or condition.
No
The device description and intended use indicate that the Flexipet® Denuding Pipettes and Manipulation Pipettes are tools for physical manipulation of cells and embryos, not for diagnosing conditions or diseases. The performance studies focus on physical properties and biocompatibility, not diagnostic accuracy.
No
The device description clearly states that the device is a physical object made of polycarbonate tubes with specific dimensions and is supplied gamma sterilized. There is no mention of software components.
Based on the provided information, the Flexipet® Denuding Pipettes and Flexipet® Manipulation Pipettes are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use is for physical manipulation of biological materials (blastomeres, polar bodies, oocytes, embryos, cumulus complex). This is a procedural tool used in assisted reproductive technologies (ART), not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical characteristics of the pipettes (material, dimensions, sterilization). It doesn't mention any components or functionalities related to analyzing biological samples or generating diagnostic information.
- Performance Studies: The performance studies focus on the physical properties and functionality of the pipettes (MEA testing for embryo development, LAL for endotoxins, cytotoxicity, aging, pull-out force, aspiration). These tests assess the safety and performance of the tool itself, not its ability to provide diagnostic information from a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, generating data for diagnosis, or any of the typical characteristics associated with IVD devices.
In summary, these devices are tools used in a laboratory setting for manipulating biological materials, not for performing diagnostic tests on those materials.
N/A
Intended Use / Indications for Use
The Flexipet® Denuding Pipettes are intended to be used for blastomere or polar body manipulation, occyte and embryo manipulation, or denuding. The Flexipet® Manipulation Pipettes are intended to be used for blastomere or polar body manipulation, oocyte and embryo manipulation, blastocyst handling, and manipulation of the oocyte-cumulus complex.
Product codes
MOH
Device Description
The Flexipet® Denuding Pipettes are polycarbonate tubes with inner diameters measuring 600 um (microns) at the proximal end which taper in diameter in a range from 120 µm to 170 µm on the distal end. The micropipettes are all 3.5 inches in length and constructed from polycarbonate. The devices are supplied gamma sterilized and are intended for one-time use.
The Flexipet® Manipulation Pipettes are polycarbonate tubes with inner diameters measuring 600 um (microns) at the proximal end which taper in diameter in a range from 80 um to 600 um on the distal end. The micropipettes are all 3.5 inches in length and constructed from polycarbonate. The devices are supplied gamma sterilized and are intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
- MEA Testing: The Flexipet® Denuding Pipettes and Flexipet® Manipulation Pipettes underwent lot-release Mouse Embryo Assay testing. The acceptance criterion was that ≥80% 1-cell embryos developed to blastocyst within 96 hours. The predetermined acceptance criterion was met.
- LAL Testing: The Flexipet® Denuding Pipettes and Flexipet® Manipulation Pipettes were lot-release tested using the Limulus Amebocyte Lysate (LAL) test. The devices must demonstrate
§ 884.6130 Assisted reproduction microtools.
(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2015
Cook Incorporated Naomi Funkhouser Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47402
Re: K150748
Trade/Device Name: Flexipet® Denuding Pipette, Flexipet® Manipulation Pipette Regulation Number: 21 CFR 884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: Class II Product Code: MOH Dated: November 18, 2015 Received: November 18, 2015
Dear Naomi Funkhouser,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150748
Device Name
Flexipet® Denuding Pipette and Flexipet® Manipulation Pipette
Indications for Use (Describe)
The Flexipet® Denuding Pipettes are intended to be used for blastomere or polar body manipulation, occyte and embryo manipulation, or denuding.
The Flexipet® Manipulation Pipettes are intended to be used for blastomere or polar body manipulation, oocyte and embryo manipulation, blastocyst handling, and manipulation of the oocyte-cumulus complex.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font, and the word "MEDICAL" is in a smaller, white, sans-serif font below it.
COOK INCORPORA NIELS WAY, P.O.
5.0 510(k) Summary
Flexipet® Denuding Pipette Flexipet® Manipulation Pipette 510(k) Summary 21 CFR §884.6130 Date Prepared: December 11, 2015
Cook Incorporated
750 Daniels Way
P.O. Box 489
Submitted By:
| Applicant: | |
|---|---|
| Address: |
Phone Number: Fax Number:
Contact: Contact Address:
Contact Phone Number: Contact Fax Number:
(812) 335-3575 x104371 (812) 332-0281 Naomi Funkhouser Cook Incorporated 750 Daniels Way
Bloomington, IN 47402
P.O. Box 489 Bloomington, IN 47402 (812) 335-3575 x104371 (812) 332-0281
Device Information:
Trade name: Common name:
Classification Name:
Regulation: Product Code: Flexipet® Denuding Pipette Flexipet® Manipulation Pipette Microtools, Assisted Reproduction (Pipettes) Assisted Reproduction Microtools. 21 CFR §884.6130 MOH
Predicate Device:
The predicate device is "THE STRIPPER®" Micropipetter and Micropipetter Tips (Mid-Atlantic Diagnostics, Inc., K993699).
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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, with a registered trademark symbol to the right of the word. Below the word "COOK" is the word "MEDICAL" in white, and both words are set against a red background.
Device Description:
The Flexipet® Denuding Pipettes are polycarbonate tubes with inner diameters measuring 600 um (microns) at the proximal end which taper in diameter in a range from 120 µm to 170 µm on the distal end. The micropipettes are all 3.5 inches in length and constructed from polycarbonate. The devices are supplied gamma sterilized and are intended for one-time use.
The Flexipet® Manipulation Pipettes are polycarbonate tubes with inner diameters measuring 600 um (microns) at the proximal end which taper in diameter in a range from 80 um to 600 um on the distal end. The micropipettes are all 3.5 inches in length and constructed from polycarbonate. The devices are supplied gamma sterilized and are intended for one-time use.
Intended Use:
The Flexipet® Denuding Pipettes are intended to be used for blastomere or polar body manipulation, oocyte and embryo manipulation, or denuding.
The Flexipet® Manipulation Pipettes are intended to be used for blastomere or polar body manipulation, oocyte and embryo manipulation, blastocyst handling, and manipulation of the oocyte-cumulus complex.
Comparison to Predicates:
The Flexipet® Denuding Pipettes and Flexipet® Manipulation Pipettes are substantially equivalent to the predicate device, "THE STRIPPER®" Micropipetter and Micropipetter Tips (Mid-Atlantic Diagnostics, Inc., K993699), in that these devices have similar designs, methods of construction and operation, and indications for use.
Technological Characteristics:
The Flexipet® Denuding Pipettes and Flexipet® Manipulation Pipettes were subjected to testing as to assure validation of design and performance.
-
- MEA Testing The Flexipet® Denuding Pipettes and Flexipet® Manipulation Pipettes underwent lot-release Mouse Embryo Assay testing. The acceptance criterion was that ≥80% 1-cell embryos developed to blastocyst within 96 hours. The predetermined acceptance criterion was met.
-
- LAL Testing The Flexipet® Denuding Pipettes and Flexipet® Manipulation Pipettes were lot-release tested using the Limulus Amebocyte Lysate (LAL) test. The devices must demonstrate